Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report

Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug Administration for New Drugs

(2021) Fang Wu et al.   AAPS Journal

Scientific considerations to move towards biowaiver for biopharmaceutical classification system class III drugs: How modeling and simulation can help

(2021) Fang Wu et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations

(2020) Lei Miao et al.   AAPS Journal

Using Physiologically Based Pharmacokinetic Modeling to Assess the Risks of Failing Bioequivalence Criteria: a Tale of Two Ibuprofen Products

(2020) Ioannis Loisios-Konstantinidis et al.   AAPS Journal

Matching phosphate and maleate buffer systems for dissolution of weak acids: Equivalence in terms of buffer capacity of bulk solution or surface pH?

(2016) Rodrigo Cristofoletti et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

The Effect of Excipients on the Permeability of BCS Class III Compounds and Implications for Biowaivers

(2015) Alan Parr et al.   PHARMACEUTICAL RESEARCH